Trials / Completed
CompletedNCT02966028
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
A Double-blind, Randomised, Placebo-controlled Study to Assess the Effect of SNF472 on Progression of Cardiovascular Calcification on Top of Standard of Care in End-stage-renal-disease (ESRD) Patients on Hemodialysis (HD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 274 (actual)
- Sponsor
- Sanifit Therapeutics S. A. · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD
Detailed description
Reducing the progression of cardiovascular calcification (CVC) in HD patients may improve the severe burden of CV disease related to the underlying ESRD. As no therapy is currently indicated to target CVC, there is a need to investigate the ability of SNF472 to reduce CVC progression and, ultimately, to improve CV outcomes in HD patients. This phase 2b double-blind, randomised, placebo-controlled study is designed to assess the effect of SNF472 on the progression of CVC as measured by calcium volume and CAC/Agatston scores in ESRD patients receiving HD. The study hypothesis is that administration of SNF472 over 52 weeks can slow the progression of CVC in this patient population compared to placebo.
Conditions
- Cardiovascular Diseases
- Cardiovascular Abnormalities
- Calcifications, Vascular
- Endstage Renal Disease
- ESRD
- Coronary Artery Calcification
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNF472 | Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions. |
| DRUG | Placebo | Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2019-08-01
- Completion
- 2019-09-01
- First posted
- 2016-11-17
- Last updated
- 2021-04-15
- Results posted
- 2021-03-16
Locations
75 sites across 3 countries: United States, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02966028. Inclusion in this directory is not an endorsement.